QUETIAPINE TECNIGEN 25 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Quetiapine TecniGen 25 mg film-coated tablets EFG

Quetiapine

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

Contents of the pack:

1. What Quetiapine TecniGen film-coated tablets are and what they are used for
2. What you need to know before you take Quetiapine TecniGen film-coated tablets
3. How to take Quetiapine TecniGen film-coated tablets
4. Possible side effects
5. Storage of Quetiapine TecniGen film-coated tablets
6. Pack contents and further information

1. What Quetiapine TecniGen film-coated tablets are and what they are used for

Quetiapine TecniGen contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine TecniGen can be used to treat several diseases, such as:

• Bipolar depression: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or have trouble sleeping.
• Mania: where you may feel very excited, elated, agitated, enthusiastic, or hyperactive, or show poor judgment, including being aggressive or violent.
• Schizophrenia: where you may hear or feel things that are not there, believe things that are not true, or feel abnormally suspicious, anxious, confused, guilty, tense, or depressed.

Your doctor may continue to prescribe Quetiapine TecniGen even when you are feeling better.

2. What you need to know before you take Quetiapine TecniGen film-coated tablets

Do not take Quetiapine TecniGen:

• If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Quetiapine TecniGen film-coated tablets (listed in section 6).

• If you are taking any of the following medicines:
• • some medicines for HIV
  • azole-type medicines (for fungal infections)
  • erythromycin or clarithromycin (for infections)
  • nefazodone (for depression)

Do not take Quetiapine TecniGen if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking Quetiapine TecniGen.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapine TecniGen if:

• You are suffering from depression or other conditions that are treated with antidepressants. The use of these medicines together with Quetiapine TecniGen may cause serotonin syndrome, a potentially life-threatening condition (see "Using Quetiapine TecniGen with other medicines").
• You, or a family member, have or have had any heart problems, such as heart rhythm problems, heart muscle weakness, or heart inflammation, or if you are taking any medicine that may affect your heart rhythm.
• You have low blood pressure.
• You have had a stroke, especially if you are elderly.
• You have liver problems.
• You have ever had a seizure (convulsion).
• You have diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while you are taking quetiapine.
• You know that you have had low white blood cell counts in the past (which may or may not have been caused by other medicines).
• You are an elderly person with dementia (loss of brain function). If so, you should not take quetiapine because the group of medicines to which Quetiapine TecniGen belongs may increase the risk of stroke, or in some cases the risk of death, in these people.
• You or a family member have a history of blood clots, as medicines like this have been associated with the formation of blood clots.

Tell your doctor immediately if, after taking Quetiapine TecniGen, you experience any of the following:

• A combination of fever, severe muscle stiffness, sweating, or a decrease in consciousness level (a disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This can increase the risk of accidental injury (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Fast and irregular heartbeats, even when at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These disorders can be caused by this type of medicine.

Tell your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as it could be a consequence of a very low white blood cell count and may require interruption of treatment with quetiapine and/or additional treatment.
• Constipation along with persistent abdominal pain, or constipation that has not responded to treatment, as it could lead to a more severe bowel obstruction.

Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This can increase when you first start treatment, as all these medicines take time to work, usually around two weeks but sometimes longer. These thoughts can also increase if you stop taking your medication abruptly. You may be more likely to think this way if you are a young adult. Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.

If at any time you think about harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a relative or close friend that you are depressed and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Weight gain

Weight gain has been observed in patients taking quetiapine. You and your doctor should monitor your weight regularly.

Children and adolescents

Quetiapine TecniGen should not be used in children and adolescents under 18 years of age.

Using Quetiapine TecniGen with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Do not take Quetiapine TecniGen if you are using any of the following medicines:

• Some medicines for HIV.
• Azole-type medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Tell your doctor if you are using any of the following medicines:

• Antidepressants. These medicines can interact with Quetiapine TecniGen, and you may experience symptoms such as involuntary muscle contractions, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor when you experience these symptoms.
• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that affect your heart rhythm, such as medicines that can cause an electrolyte imbalance (low potassium or magnesium levels), such as diuretics (medicines to urinate) or certain antibiotics.
• Medicines that can cause constipation.

Before stopping any of your medicines, consult your doctor first.

Taking Quetiapine TecniGen film-coated tablets with food, drinks, and alcohol

• Quetiapine TecniGen can be taken with or without food.
• Be careful with the amount of alcohol you drink. This is because the combined effect of Quetiapine TecniGen and alcohol can make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine TecniGen. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You should not take Quetiapine TecniGen during pregnancy, unless your doctor has advised you to do so. You should not use Quetiapine TecniGen if you are breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may appear in newborn babies of mothers who have used quetiapine in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and using machines

These tablets can make you feel drowsy. Do not drive or operate tools or machines until you know how the tablets affect you.

Quetiapine TecniGen film-coated tablets contain lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Effect on urine drug screening tests

If you are having a urine drug screening test, taking quetiapine may produce positive results for methadone or certain antidepressants called tricyclic antidepressants (TCAs) when some analytical methods are used, even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.

3. How to take Quetiapine TecniGen film-coated tablets

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your disease and needs but will normally be between 150 mg and 800 mg.

• You will take your tablets once a day, at bedtime, or twice a day, depending on your disease.
• Swallow your tablets whole with water.
• You can take the tablets with or without food.
• Do not drink grapefruit juice while taking Quetiapine TecniGen. It may affect how the medicine works.
• Do not stop taking your tablets, even if you feel better, unless your doctor tells you to.

Liver problems

If you have liver problems, your doctor may change your dose.

Elderly people

If you are elderly, your doctor may change your dose.

Use in children and adolescents

Quetiapine TecniGen should not be used in children and adolescents under 18 years of age.

If you take more Quetiapine TecniGen than you should

If you take more Quetiapine TecniGen than your doctor has prescribed, you may feel drowsy, dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring the Quetiapine TecniGen tablets with you.

You can also call the Toxicology Information Service, Telephone: 915620420, indicating the medicine and the amount taken.

If you forget to take Quetiapine TecniGen

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait until then. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Quetiapine TecniGen

If you stop taking Quetiapine TecniGen abruptly, you may experience insomnia, nausea, headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest gradually reducing the dose before stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very Common Adverse Effects (may affect more than 1 in 10 people):

• Dizziness (may lead to falls), headache, dry mouth.
• Feeling of drowsiness (which may disappear over time, as you continue taking quetiapine), (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common Adverse Effects (may affect up to 1 in 10 people):

• Rapid heartbeat.
• Feeling like your heart is beating strongly, rapidly, or skipping beats.
• Constipation, upset stomach (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing up. This can make you feel dizzy or faint (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increase in liver enzymes measured in the blood.
• Increase in the amount of prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:
• • In both men and women, swelling of the breasts and unexpected milk production.
  • In women, not having menstrual periods or having irregular periods.

Uncommon Adverse Effects (may affect up to 1 in 100 people):

• Seizures or convulsions.
• Allergic reactions that can include hives, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart seen on an ECG (prolongation of the QT interval).
• Slower heart rate than normal, which can occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in the blood.
• Decrease in the amount of sodium in the blood.

Rare Adverse Effects (may affect up to 1 in 1,000 people):

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a disorder called "neuroleptic malignant syndrome").
• Yellowish color in the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Swelling of the breasts and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Walking, talking, eating, or other activities while you are asleep.
• Decreased body temperature (hypothermia).
• Pancreas inflammation.
• A condition (called "metabolic syndrome") in which you may have a combination of three or more of the following effects: increased fat around your abdomen, decreased "good" cholesterol (HDL-C), increased triglycerides, increased blood pressure, and increased blood sugar.
• A combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition called agranulocytosis.
• Intestinal obstruction.
• Increased creatine phosphokinase in the blood (a substance found in muscles).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reaction (called anaphylaxis) that can cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A severe condition of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

Unknown Frequency (cannot be estimated from available data)

• Skin rash with irregular red spots (erythema multiforme).
• Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs involved (drug rash with eosinophilia and systemic symptoms, also known as DRESS). If you develop these symptoms, stop using quetiapine and contact your doctor or seek immediate medical attention.
• Heart muscle disorder (cardiomyopathy)
• Heart muscle inflammation (myocarditis)
• Inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple spots.

The class of medicines to which Quetiapina TecniGen belongs may cause heart rhythm problems that can be serious and, in severe cases, potentially fatal.

Some adverse effects are only observed when a blood test is performed. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in your blood, increased liver enzymes, decreased number of certain types of blood cells, decreased red blood cell count, increased creatine phosphokinase in the blood (a substance found in muscles), decreased sodium in the blood, and increased prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:

• In both men and women, swelling of the breasts and unexpected milk production.
• In women, not having menstrual periods or having irregular periods.

Your doctor may ask you to have blood tests from time to time.

Adverse Effects in Children and Adolescents

The same adverse effects that can occur in adults can also occur in children and adolescents.

The following adverse effects have been observed more frequently in children and adolescents or have not been observed in adults:

Very Common Adverse Effects (may affect more than 1 in 10 people):

• Increase in the amount of a hormone called prolactin in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:
• • In both boys and girls, swelling of the breasts and unexpected milk production.
  • In girls, not having menstrual periods or having irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

Common Adverse Effects (may affect up to 1 in 10 people):

• Feeling of weakness, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https//www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Quetiapina TecniGen Film-Coated Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Quetiapina TecniGen Film-Coated Tablets

The active ingredient is quetiapine. The tablets contain 25 mg of quetiapine (as quetiapine fumarate).

The other ingredients are:

Tablet core:

Calcium hydrogen phosphate anhydrous, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone, magnesium stearate.

Tablet coating:

Hypromellose, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of Quetiapina TecniGen Film-Coated Tablets and Package Contents

The tablets are round, biconvex, and peach-colored.

They are presented in PVC/PE/PVDC/aluminum blisters with 1, 3, 6, 10, 20, 28, 30, 50, 60, 90, 98, 100, 120, 180, or 240 tablets, or 30x1, 100x1 (combined packaging).

They may also be presented in HDPE bottles with 60 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega, 28108 Alcobendas (Madrid) SPAIN

Manufacturer

HBM Pharma s.r.o.

Sklabinská 30

03680 Martin

Slovene Republic

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2,

Abrunheira. 2710 – 089 Sintra (Portugal).

Bluepharma - Indústria Farmacêutica, S.A.,

• Martinho do Bispo,

Coimbra,

3045-016, Portugal

Date of Last Revision of this Leaflet: July 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/